Pharmaceutical companies deal with stringent regulations whenever they submit product information (PI) into a worldwide product registration process. This is a critical process, as it determines how well decades of discovery and clinical investments will be understood and adopted by stakeholders including patients, healthcare professionals, and payers. Submitting product information, and doing it accurately the first time, directly impacts corporate revenues, company reputation, and future medical advances.
Constant label changes
Formal regulations, which vary by geography, stipulate how PI has to pass regulatory review. In the EU, PI validation could be done in up to 24 languages. Moreover, global pharmaceutical companies typically conduct business in as many as 50+ languages, with data requiring constant updates and regional coordination. Currently, there are a limited number of new chemical or biological substances which are entering the market as initial submissions. However, advances in medical practice and pharmacovigilance are driving the requirements for continual updates of PI across the globe. In practice, this means that every drug manufacturer with an active portfolio is facing thousands of yearly updates to required translation projects with very tight timelines, hundreds of stakeholders and strict procedures in order to gain regulatory approvals.
The unique pharmaceutical labeling challenge
The process to create a new drug is extremely complex. There are several important requirements related to language translation in the labeling process:
- During the label change process, regulators require that the science team mark all requested amendments in the original submission using Microsoft Word’s “Track Changes" and “Comments" feature.
- The applicant then must prove that all changes in the source documents have been adequately reflected in each of the targeted languages, again using Microsoft Word Track Changes and Comments.
- The regulations further stipulate that there be proof that no other portions of the text have been altered in any way.
Managing changes in this mandated way creates technical challenges for labeling managers beyond just language translation. Given this challenge, companies can look to automate the process, however most automated translation solutions today work on the entire body of the text and do not support the processing of tracked changes in the way outlined by governmental regulations. Existing translation tools have not been designed to support these specialized requirements. Additionally, current systems are not concerned with recording, preserving and displaying an audit trail of the changes in the final output. In most non-regulated instances, users are only concerned with seeing the final translated document as it will be seen by the end user. However, when regulators review translated PI they also want to see the final translated content with tracked changes. This, therefore, is a unique challenge for pharmaceutical companies and one we will explore further.
In subsequent articles, we will expand on this discussion on multilingual labeling by deliberating on the far-reaching consequences of poor regulatory labeling as well as how technology can improve the regulatory labeling submission process.